Why does a patient have to be on a regimen of carbidopa/levodopa (CD/LD) in order to take INBRIJA?
INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with CD/LD. INBRIJA has been shown to be effective only in combination with CD/LD.
Can INBRIJA be taken first thing in the morning for morning OFF/early morning OFF?
INBRIJA should be taken when symptoms of an OFF period start to return, as needed, as an 84 mg dose; no more than 1 dose per OFF period and up to a maximum of 5 doses per day. The morning OFF is a type of OFF period. Use of INBRIJA is not limited to any specific times of day or number of hours since the most recent dose of CD/LD.
A safety study assessed use of INBRIJA at the same time as oral CD/LD for morning OFF periods in 36 patients.
Based on the results of this study, an amendment to the 1‑year extension study of SPANSM‑PD was made and allowed use of INBRIJA for early‑morning OFF, which was excluded in the SPAN‑PD phase 3 pivotal trial.23
What is the incidence and severity of cough with INBRIJA?
Patients should be advised that inhalation of INBRIJA can lead to coughing at the time of administration.
During the 12‑week pivotal trial, cough was reported in 15% of the 114 patients on INBRIJA 84 mg compared with 2% of the 112 patients in the placebo group. Of the 17 patients that reported cough in the 84 mg treatment arm, 11 patients and six patients reported cough as mild or moderate, respectively; no severe cough was reported. Of these 17 patients, 14 patients reported cough within the first 30 days of treatment.1,19 Two patients taking INBRIJA 84 mg discontinued treatment because of cough.
Of the patients who reported cough in this study, cough was more common (25% vs 5%) in patients 65 years or older (n=56) than patients younger than 65 (n=58).
If my patients have asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease, why shouldn't I prescribe INBRIJA?
The use of INBRIJA in patients with asthma, COPD, or other chronic underlying lung disease is not recommended because of the risk of bronchospasm.
In a double‑blind, placebo‑controlled crossover study, 25 otherwise healthy subjects with mild/moderate asthma on a stable regimen of asthma medication experienced more cough with INBRIJA (60%) vs placebo (0%). Ten subjects (40%) had temporary reductions from baseline (15‑59%) in FEV1 with INBRIJA compared to 4 subjects (16%) with placebo.
Ask patients to report whether they develop asthma, COPD, or other chronic lung diseases, since INBRIJA is not recommended in patients with these conditions.
Use of INBRIJA
How do I teach my patients to use INBRIJA?
It is important for patients to understand how to correctly use INBRIJA prior to use. Patients should be counseled to take a dose (84 mg) of INBRIJA when the return of their Parkinson’s symptoms (OFF periods) first occur.
In addition to in-office instruction, advise patients to read the Instructions For Use before using INBRIJA. It is important to remind patients of the following instructions:
INBRIJA capsules should only be administered via the INBRIJA inhaler and the INBRIJA inhaler should not be used for administering other medications
The contents of INBRIJA capsules are for oral inhalation only and must not be swallowed
INBRIJA capsules are to be kept in their sealed blister packaging and each INBRIJA capsule is to be removed immediately before using
Two capsules must be orally inhaled in order to take a full dose
No more than 5 doses of INBRIJA should be taken in one day
No more than one dose (2 capsules) should be taken per OFF period
Will my patients be able to use the INBRIJA inhaler even while experiencing symptoms of OFF periods?
In 2 clinical trials, 99.8% (628 of 629) of patients demonstrated the ability to self-administer INBRIJA while in an OFF period after instruction.1
Support for using INBRIJA
How do I prescribe INBRIJA?
Detailed instructions for prescribing INBRIJA are available on this website. The first step to prescribing is filling out and submitting the Prescription Request Form (PRF) for INBRIJA. Download the PRF form here. Your INBRIJA representative can also assist you with information on how to prescribe INBRIJA.
Does Acorda offer financial assistance to patients who cannot afford INBRIJA?
The Patient Assistance Program (PAP) is available to help patients, if eligible, gain access to INBRIJA at no cost to them. The INBRIJA Co‑pay Assistance program may help commercially insured (non-government funded) patients lower their out‑of‑pocket costs.
Can my patients get INBRIJA at their local pharmacy?
INBRIJA is available only through a limited network of specialty pharmacies.
Intermittent treatment of OFF episodes in patients with PD treated with CD/LD.
Important Safety Information
Contraindication: nonselective MAOIs (e.g., phenelzine, tranylcypromine) due to hypertension risk. Discontinue their use at least 2 weeks prior to initiating INBRIJA.
Not recommended in patients with asthma/COPD/other chronic lung disease due to bronchospasm risk.
INBRIJA is indicated for intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD) treated with carbidopa/levodopa.
Important Safety Information
INBRIJA is contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to risk of hypertension. Discontinue use of nonselective MAO inhibitors at least 2 weeks prior to initiating INBRIJA.
Patients treated with levodopa, the active ingredient in INBRIJA, have reported falling asleep during activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Many patients reported somnolence but some reported no warning signs (sleep attack). This may occur more than a year after initiating treatment. Reassess patients for drowsiness/sleepiness including occurrence during specific activities. Advise patients of potential for drowsiness and ask about factors that may increase this risk (e.g., sedating medications, sleep disorders).
Consider discontinuing INBRIJA in patients who report significant daytime sleepiness or falling asleep during activities that require active participation. If continuing INBRIJA, advise patients not to drive and to avoid activities that may result in harm. There is insufficient information that dose reduction will eliminate episodes of falling asleep during activities of daily living.
Neuroleptic malignant syndrome-like symptoms (e.g., elevated temperature, muscular rigidity, altered consciousness, autonomic instability) have been reported with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy.
Hallucinations (with or without confusion, insomnia, and excessive dreaming) may occur and may respond to reducing levodopa therapy. Abnormal thinking and behavior may present with paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium.
INBRIJA should ordinarily not be used in patients with major psychotic disorder due to risk of exacerbating psychosis. Dopamine antagonists used to treat psychosis may exacerbate symptoms of PD and may decrease INBRIJA efficacy.
Patients on medications that increase central dopaminergic tone such as INBRIJA can experience intense urges to gamble or spend money, increased sexual urges, binge eating, and/or other intense urges, and inability to control them. In some cases, these urges stopped with dose reduction or medication discontinuation. Since some patients may not recognize these behaviors as abnormal, ask patients or their caregivers about development of new or increased urges and consider stopping INBRIJA if this occurs.
INBRIJA may cause or exacerbate dyskinesias. If troublesome dyskinesias occur, consider stopping INBRIJA or adjusting other PD medications.
INBRIJA is not recommended in patients with asthma, COPD, or other chronic underlying lung disease because of the risk of bronchospasm.
Monitor patients with glaucoma for increased intraocular pressure.
Abnormalities in laboratory tests may include elevations of liver function tests (e.g., alkaline phosphatase, AST, ALT, lactic dehydrogenase, bilirubin), blood urea nitrogen, hemolytic anemia, and positive direct antibody test. Increased levels of catecholamines and their metabolites in plasma and urine may result in false-positive results suggesting pheochromocytoma.
The most common adverse reactions (≥ 5% and > placebo) were cough (15% vs 2%), upper respiratory tract infection (6% vs 3%), nausea (5% vs 3%), and sputum discolored (5% vs 0%).
Use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients taking these drugs concurrently.
Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce levodopa efficacy; monitor for worsening symptoms.
Iron salts or multivitamins with iron salts may reduce levodopa bioavailability.
INBRIJA should be used during pregnancy/nursing only if potential benefit justifies potential risk. There are no adequate data on INBRIJA in pregnant women or breastfed infants. Animal data shows carbidopa/levodopa is developmentally toxic (including teratogenicity). Levodopa may affect milk production, interfering with lactation. Levodopa has been detected in human milk.
Safety and effectiveness in pediatric patients have not been established.
Geriatric patients (n=56) experienced more of the following adverse reactions than patients <65 (n=58): cough (25% vs 5%), upper respiratory tract infection (11% vs 2%), nausea (7% vs 3%), vomiting (4% vs 2%), pain in extremities (4% vs 0%), and discolored nasal discharge (4% vs 0%).
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